Validation of a Tolerability Questionnaire in Rheumatoid Arthritis
NCT ID: NCT02401620
Last Updated: 2015-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
66 participants
OBSERVATIONAL
2014-01-31
2015-12-31
Brief Summary
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Detailed Description
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The first phase of the development of the questionnaire has already been completed. The second phase of the development of the questionnaire has been designed at to validate the tool in the Spanish population.
This study aims to assess the measurement properties of a new tool which assesses the impact of daily life in Rheumatoid Arthritis.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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single-group studies
Patients with RA diagnosed
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients with RA diagnosed according to the standards of the ACR (American College of Rheumatology) in 1987 or to the ACR/EULAR in 2010
3. Patients on treatment with any Rheumatoid Arthritis drug for at least 3 months before their inclusion in the study \*
4. Patients who have provided informed consent prior to taking part in the study.
* It's not necessary for patients to be treated in first-line at the moment of the inclusion in the study.
Exclusion Criteria
2. Patients with any other concomitant disease or treatment that, under clinical criteria, could affect the results of the study or any major episode of infection or disease requiring hospitalization.
3. Patients with any other medical or physiological condition that, in the view of the investigator, could compromise the ability of the patient to answer the study questions.
4. Patients who participated in interviews of the Phase I (development of the questionnaire)
18 Years
ALL
No
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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Antonio D Gómez-Centeno
MD
Principal Investigators
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Antoni Gomez Centeno
Role: STUDY_CHAIR
Hospital Corporacio Parc Tauli
Locations
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Hospital Clínic
Barcelona, Barcelona, Spain
Hospital Moisés Broggi
Sant Joan Despí, Barcelona, Spain
Hospital Can Misses
Ibiza Town, Ibiza, Spain
Hospital Son Espases
Mallorca, Mallorca, Spain
Hospital Son Llàtzer
Mallorca, Mallorca, Spain
Hospital Corporacio Sanitaria Parc Tauli
Sabadell, Spain, Spain
Countries
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Central Contacts
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Facility Contacts
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Raimón Sanmartí
Role: primary
Hector Coromines
Role: primary
Ana Urruticoechea
Role: primary
Lluis Espadaler
Role: primary
Inmaculada Ros
Role: primary
Antoni Gomez Centeno
Role: primary
Other Identifiers
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FUN-TOC-2014-01
Identifier Type: -
Identifier Source: org_study_id
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